The Recall Desk

FDA (Devices) recall action 78321

Zimmer Dental Inc recalled 4 products on 2017-12-27

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2017-12-27
Critical
0
Units
1,443

Why these products were recalled

The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2017-12-27

    Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 356 GemLock RHD2.5 Hex Drivers because a manufacturing defect may prevent the tool from properly engaging dental fixtures.

    Product
    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-12-27

    Zimmer Dental Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 30 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-12-27

    Zimmer Dental Tapered Screw-Vent Implant Surgical Kits Recalled for Geometry Defect

    Zimmer Dental Inc. is recalling 891 Tapered Screw-Vent Implant System surgical kits because a manufacturing defect in the driver's hex feature may prevent proper engagement with dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-12-27

    Zimmer Dental Implant Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 166 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in…
    Category
    Distribution
    0 states